CIRS compiles the positive list of new food raw material

1 August, 2014

The National Health and Family Planning Commission of the People’s Republic of China (NHFPC) have published hundreds of new food raw materials since 1988. CIRS’s food regulatory team has compiled the positive list of new food raw materials from 1988 to 2014 (please refer to the table at the end of this article which shows the positive list of new food material from 2013 to 2014). CIRS hopes to help you to know the industry dynamic clearly.

What is new food raw material?

New food materials refer to the following objects/materials that are not traditionally consumed in China:

1. Animal, plant and microorganisms;

2. Substances derived from animals, plants and microorganisms;

3. Food substances whose structure has changed;

4. Other newly developed food materials.

Why to apply for the permit of new food raw materials?

The administrative measures for safety review of new food materials have been issued by National Health and Family Planning Commission (NHFPC) on 31 May 2013. This regulation has come into force on 1 October 2013. Companies should apply to the certificate for their new food materials prior to making the materials available in the Chinese market.

How to apply?

Regulation on application approaches of new food material and regulation on safety assessment of new food materials have been issued by NHFPC on 15 October 2013 and came into force immediately. These provisions have specified the data requirements, application, safety assessment and On-site examination.

Data requirements

1. Component analysis report

2. Hygienic test report

3. Toxicity studies reports

4. Resistant microbe and toxin producing ability test report

5. Safety assessment report

The toxicity studies reports, the resistant microbe and toxin producing ability test report could be provided by oversea laboratories with OECD GLP qualification. Other studies should be conducted in China by test laboratories with CMAF qualification. ;

Toxicity studies for various product categories

In accordance with the Regulation on application approaches of new food material, the data requirements are different for various product categories of new food material application in China:

Test items

Animal and plant sources

Microorganisms sources

Is that traditionally consumed outside of China?

NO

Yes, only in few countries.

Yes, it has been widely consumed in other countries

NO

Yes, only in few countries.

Yes, it has been widely consumed in other countries

1

Acute oral toxicity test

×

×

×

×

×

×

2

Three genetic toxicity tests

×

×

×

×

×

-

3

Two genetic toxicity tests

-

-

-

-

-

×

4

90 days oral toxicity test

×

×

-

×

×

-

5

28 days oral toxicity test

-

-

×

-

-

-

6

Teratogenicity test

×

×

-

×

-

-

7

Reproductive toxicity test

×

×*

-

×

-

-

8

Chronic toxicity and carcinogenicity tests

×

-

-

-

-

-

9

Metabolic test

×

-

-

-

-

-

*In the case of there being any study reports or reference materials that can prove there is no toxic affect from this new food material, and there is no harmful reaction in long-term edible history from this new food material, the reproductive toxicity test could be exempted for Animal and Plant sources new food material, which has been traditionally consumed in few countries outside of China.

From the positive list of new food raw materials from 1988 to 2014, we can know whether the raw material have been permitted yet. Furthermore, some new food raw materials are only permitted to use in certain foods. For example, the tagatose could be added into every food except infant food. Tea blossom would be used without limits of application scope and intake. D-Fructose 1, 6-diphosphate trisodium salt is merely allowed to be used in sports drink, but not for infant and pregnant women. Meanwhile, the acceptable daily intake is 300mg.

We would offer you consulting service for free before 1 September 2014, such as checking whether the raw material is a permitted new food raw material, the scope of application and so on. If you would like to get the detailed positive list or other relevant information, pleases send us an email.